Phase 4
N=1,137
A Study of LUMIGAN® RC in the Clinical Setting
Glaucoma, Primary Open Angle · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01833741 ↗Enrolled (actual)
1,137
Serious AEs
0.3%
Results posted
Sep 2013
Primary outcome: Primary: Percentage of Treatment-Naive Patients With Ocular Hyperemia — 32.2; 39.8; 21.3; 5.9 Percentage of Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bimatoprost 0.01% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Treatment-Naive Patients With Ocular Hyperemia |
32.2; 39.8; 21.3; 5.9; 0.9 | — |
| PRIMARY Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia |
35.5; 41.0; 17.3; 6.0; 0.3 | — |
| PRIMARY Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia |
28.4; 36.9; 24.1; 9.2; 1.4 | — |
| SECONDARY Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients |
-30.9 | — |
| SECONDARY Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients |
-16.1 | — |
| SECONDARY Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy |
-16.1 | — |
| SECONDARY Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients |
23.5; -7.4; -7.7 | — |
| SECONDARY Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients |
20.3; -3.5; -3.7 | — |
| SECONDARY Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy |
20.8; -3.8; -3.7 | — |
| SECONDARY Percentage of Patients Discontinuing Due to Ocular Adverse Events |
3.9 | — |
Summary
This study will evaluate bimatoprost 0.01% (LUMIGAN® RC) in patients with elevated intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension (OHT) in a clinical setting.
Eligibility Criteria
Inclusion Criteria
- Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
- Determined by the treating physician to require treatment with LUMIGAN® RC
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01833741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.